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The Cancer Genome Atlas (TCGA) Barcode
Clinical Data Reporting Internal Use Only
Form - Ovarian
1. Completed By:
Tissue Source Site(TSS) Name:________________________
_____________________
TSS Identifier #: Date: /
/
M M D
Tier 1 Clinical Data Definition: All of these elements (1-22) are D Y Y
required to _qualify_ the tumor specimen for TCGA project. 2. Completed By:
Tier 1 Clinical Data (Page 1 of 3) ______________________
Date:
Tier # Data Element Label Entry Alternatives caBIG Definition M M D
1: 01 TSSI Unique Patient # D Y Y
1: 02 Organ of Origin _ Ovary Brain Whole organ level. Text term for originating or
Lung primary anatomic site of the disease/condition
Ovary under investigation or review. (2735776)
1: 03 Histological Type: Ovarian The description of the microscopic pattern
(Serous carcinoma) indicating the degree of similarity between the
Yes tumor and the tissue of origin.
No
1:04 Gender Text designations that identify gender. Gender is
Male described as the assemblage of properties that
Female distinguish people on the basis on their social
roles. [ Explanatory Comment 1: Identification of
gender is based upon self-report and may come
from a form, questionnaire, interview, etc.
(2200604)
1: 05 Date of Birth Date on which the patient/participant was born.
/ / (2201154)
MM D D Y Y
1: 06 Reserved for Future Use
1: 07 Tobacco smoking history Text indicator to represent a person_s tobacco
indicator (Ovary-GBM: N/A) smoking, the act of puffing and/or inhaling smoke
Yes from a lit tobacco cigarette, cigar, or pipe.
No (2436233)
1: 08 Date of initial pathologic N/A The date this disease was first diagnosed. (58204)
diagnosis /
/
1: 09 Neo-adjuvant (pre-operative) MM DD Therapy includes any of the following: Radiation/
therapy Y Yes Chemo/ Immuno/ Hormonal Therapy. The yes/no
No indicator to ask whether any treatment was given
the patient prior to surgery.
1: 10 Date of Surgical Resection The date of a surgical procedure.
/ /
MM D D Y Y
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TCGA Clinical Data Reporting Form - Ovary Barcode
TSS Name:_________________ TSS Internal Use Only
#:
IdentifierTSS Unique Patient #: _____________________
Tier 1 Clinical Data (Page 2 of 3)
Tier # Data Element Label Entry Alternatives caBIG Definition
1: 11 Tumor stage (pathological) Primary Tumor (T) Each tumor will have it_s AJCC format or
Ovary (FIGO Staging system) Stage [1] other internationally accepted
[1A] nomenclature.
[1B]
[1C]
Stage [II]
[IIA]
[IIB]
1: 12 Tumor Grade [IIC]
GX: Grade cannot Numeric value to express the degree of
be assessed Stage [III] abnormality of cancer cells, a measure of
[IIIA]
GB: Border line differentiation and aggressiveness.
malignancy
[IIIB]
G1: Well
differentiated
[IIIC]
G2: Moderately
differentiatedStage [IV]
G3- G4: Poorly
differentiated or
Undifferentiated
1: 13 Complete Excision (RO) Yes (RO) RO: Surgical margins free of tumor grossly
No (R1) and microscopically. No evidence of residual
Unknown disease following surgery.
R1: Residual disease present (local, regional,
or distant)
New CDE to be created
1: 14 Adjuvant (Post-operative) Yes
Irradiation therapy No Yes/no indicator to ask if therapeutic
application if radiation was initiated to treat
disease following surgery to remove tumor
and associated malignant tissue.
1: 15 Adjuvant (Post-operative) Yes
Chemotherapy No Did the patient receive adjuvant cytoxic
therapy?
1: 16 Adjuvant (Post-operative) Yes
Immunotherapy No Yes/no indicator to ask if whether the
patient had previous immunotherapy as
preventative treatment for an earlier stage
or this cancer.
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TCGA Clinical Data Reporting Form - Ovary Barcode
TSS Name:_________________ TSS Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 1 Clinical Data (Page 3 of 3)
Tier # Data Element Label Entry Alternatives caBIG Definition
1: 17 Adjuvant (Post-operative) Yes
Hormonal therapy No Yes/no/unknown indicator whether
adjuvant hormone therapy was administered
following surgery
1: 18 Adjuvant (Post-operative)
_Targeted_ Molecular Yes
Therapy
1: 19 Date of first Recurrence after No N/A The date when the return or spread of cancer was
therapy first diagnosed.
/
/
1: 20 Date of last contact MM D D The date of the last successful contact with the
Y Y patient, family member, or caregiver to establish
(clinical evaluation) /
/ responses for 1:21 and 1:22 below
MM D D
Y Y
1: 21 Vital Status Living Test summary level description of patient /
participant survival status
Deceased
1: 22 Date of Death NA The actual date of a patients/participants death
/ /
MM D D Y Y
Comments:
____________________________________________________________________________________
_
____________________________________________________________________________________
_
____________________________________________________________________________________
_
_______________________ _____________________ / /
Principal Investigator Signature Print Name MM D D
Y Y
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The Cancer Genome Atlas (TCGA) Barcode
Clinical Data Internal Use Only
Reporting Form 1. Completed By:
Tissue Source Site(TSS) Name:________________________
_____________________
Date: /
TSS Identifier #:
/
M M D
TSS Unique Patient #:___________________ D Y Y
Tier 2 Clinical Data Definition: Desirable, but not manditory 2. Completed By:
clinical
Tier 2 Clinical Data (Page 1 analyses.
information for clinical correlationof ______________________
Date:
10)
Tier # Data Element Label Entry Alternatives caBIG Definition M M D
2: 02 Anatomic Organ Sub- Brain N/A D Y Y Anatomic organ: Text term for originating of
primary anatomic site of the disease/condition
Division
under investigation or review. (2735776)
a. Brain Lung R Upper MiddleFor tumors in paired organs, designates the
b. Lung Lower side on which was obtained (2007875)
c. Ovary L Upper
Lower
Ovary R Pack years: The number of packs (of cigarettes)
2: 07 Tobacco current use No: # years quit L
smoked per day times the number of years
YRS
smoked (2546448)
No. years quit: Total time period during when
Yes: Pack Yrs an individual did not smoke, expressed in
number of years. (2181903)
Pack years: (256448)
2: 08 Method of initial pathologic Cytology (e.g. Peritonealor pleural fluid) Method: Name of the procedure used to secure
Fine needle aspiration biopsy tissue for the original pathologic diagnosis.
diagnosis
Incision biopsy (2757941)
Excisional biopsy Other method: Test to describe a method used
to secure tissue for an original pathologic
Tumor resection
diagnosis that is different from other methods.
Other method, specify: (2757948)
Unknown
2: 09A Neo-adjuvant No Name of the neo-adjuvant radiation therapy
type administered preoperatively to an
(pre-operative) Yes Type:
individual (2757957)
Irradiation therapy ExternalOther type: Name of neo-adjuvant radiation
beam therapy type administered preoperatively that
is different from other identified types
(2757964)
Impants
Start date: Date neo-adjuvant preoperative
radiation therapy began. (2759142)
Radioisotopes Stop date: Date neo-adjuvant preoperative
radiation therapy ended. (2759144)
Dosage: Text description of the total dose of
Combinaton
radiation therapy administered to an individual
Other expressed as a dosage amount and unit of
measure (UOM). (2721441)
Specify Source:___________________ Fractions: The total number of radiation
therapy sessions (fractions) which the patient
________________________________ has completed to receive the required radiation
dose to primary treatment fields. (61465)
Start Date: / /
MM D D
Y Y
End Date: / /
MM D D
Y Y
Dosage: centi-Gray
/ Rads
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mille-curie
# of fractions:
TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e
Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 2 Clinical Data (Page 2 of
10)
Tier # Data Element Label Entry Alternatives caBIG Definition
2: 09B Neo-adjuvant (pre- No Start Date: The date on which prior neo-
adjuvant chemotherapy treatment started.
operative) Chemotherapy Yes
(62690)
Root of administration: Stop Date: The total number of cycles (courses)
Oral administered to the patient of a protocol
Intravenous (IV) specified drug or therapy agent. (62590)
Intra-peritoneal (IP)
IV and IP Drug Used: Name of a neo-adjuvant agent
administered to an individual. (2758212)
Other: Specify
_____________________
Total Dosage given: Agent total cumulative
dose (1515)
Start Date: /
/
MM D
D Y Y
End Date: /
/
MM D
D Y Y
1
of
# 2 cycles give:
3
Drugs used Total dose given
2: 09C Neo-adjuvant (pre- No Start Date: the start date of neo-adjuvant
operative) Yes hormone therapy. (2199659)
Hormone therapy
Start Date: / Stop Date: The date neo-adjuvant hormonal
therapy ended. (2199665)
/
MM D
D Y Y Drugs Used: Name of the neo-adjuvant
hormonal prior therapy agent administered to
an individual. (2758641)
End Date: /
/
# of cycles: The total number of cycles (courses)
MM D administered to the patient f a protocol
D Y Y specified drug of therapy agent. (62590)
1
2
# of cycles give: Total dose given: Agent total cumulative dose.
3 (1515)
Drugs used Total dose given
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TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e
Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 2 Clinical Data (Page 3 of
10)
Tier # Data Element Entry Alternatives caBIG Definition
2: 09D Neo-adjuvant (pre- No Start Date: Date that neo-adjuvant
Yes immunotherapy began. (2758923)
operative) Stop Date: Date that neo-adjuvant
Immunotherapy Start Date: /
immunotherapy ended. (2759147)
/ Drug Used: Name of a neo-adjuvant
MM D D immunotherapy agent administered to an
Y Y individual. (2759151)
# of cycles: The total number of cycles (courses)
administered to the patient f a protocol
End Date: /
specified drug of therapy agent. (62590)
/ Total Dosage given: Agent total cumulative
MM D dose (1515)
D Y Y
1
of
# 2 cycles give:
3
Drugs used Total dose given
2: 11A Definition of Tumor Spread
(FIGO) I: Tumor limited to ovaries (one or both)
IA: Tumor limited to one ovary: capsule
intact, no tumor on ovarian surface. No
malignant cells in ascites or peritoneas washings.
IB: Tumor limited to both ovaries; capsules
intact, no tumor on ovarian surface. No
malignant cells in ascites or peritoneal washings.
IC: Tumor limited to one or both ovaries
with any of the following: capsule ruptured,
tumor on ovarian surface, malignant cells in
ascites or peritoneal washings.
II: Tumor involves one or both ovaries with
pelvic extension.
IIA: Extension and/or implants on uterus
and/or tube(s). No malignant cells in ascites or
peritoneal washings.
IIB: Extension to other pelvic tissues. No
malignant cells in ascites or peritoneal washings.
IIC: Pelvic extension (2a or 2b) with
malignant cells in ascites or peritoneal washings.
III: Tumor involves one or both ovaries with
microscopically confirmed peritoneal metastasis
outside the pelvis and/or regional lymph node
metastasis.
IIIA: Microscopic peritoneal metastasis
beyond pelvis
IIIB: Macroscopic peritoneal metastasis
beyond pelvis 2cm or less in greatest dimension.
IIIC: Feritoneal metastasis beyond pelvis
more than 2cm in greatest dimension and/or
regional lymph node metastasis.
IV: Distant metastasis (excludes peritoneal
metastasis)
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TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e Internal
Identifier #: TSS Unique Patient # Use Only
_____________________
Tier 1 Clinical Data (Page 4 of
10)
Tier # Data Element Entry Alternatives caBIG Definition
2: 11B Number of regional lymph # examined Indicator: Text term to signify the presence of
microscopic disease in regional lymph nod(s)
nodes examined
(2759195)
microscopically # positive for tumor Number: Numeric count of regional lymph
nodes with microscopic disease involvement.
(2759157)
Examined, but # unknown = 98
Unknown if lymph nodes were
examined (NX..99)
2: 11C Metastasis Definition See 2.11A above
2: 11D Vascular Invasion Negative for venous invasion An indicator to ask if large vessel or
venous invasion was detected by surgery
Positive for venous invasion or presence in tumor specimen. (64358
information to be derived from pathology
reports (CDE # 64358)
Unknown for venous invasion
2: 11E Lymphatic Invasion Negative for lymphatic invasion An indicator to ask if malignant cells are
present on small or thin-walled vessels
Positive for lymphatic invasion suggesting lymphatic involvement.
(64171)
Unknown for lymphatic invasion
2: 13 Tumor Residual Disease: None New CDE Required
ovary 1-10
(For largest remaining mm
Nodule) 11-20
mm
>20 mm
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TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e
Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 2 Clinical Data (Page 5 of
10)
Tier # Data Element Entry Alternatives caBIG Definition
2: 14 No CDE Definition (Type) Name of the neo-
Adjuvant adjuvant radiation therapy type administered
Yes Type: preoperatively to an individual (2757957)
(Post-operative) External
Other Type: Name of the neo-adjuvant
Irradiation therapy beam radiation therapy type administered
preoperatively that is different from other
identified types (2757964)
Impants Start Date: Date neo-adjuvant preoperative
radiation therapy began. (2759142)
Radioisotopes Stop Date: Date neo-adjuvant preoperative
radiation therapy ended. (2759144)
Dosage: Text description of the total dose of
Combinaton radiation therapy administered to an individual
Other expressed as a dosage amount and unit of
measure (UOM). (2721441)
Fractions: The total number of radiation
Specify Source:___________________ therapy sessions (fractions) which the patient
________________________________ has completed to receive the required radiation
dose to primary treatment fields. (61465)
Start Date: / /
MM D D
Y Y
End Date: / /
MM D D
2: 15 Adjuvant (Post-operative) Y NoY Start Date: the start date for previous
Dosage: chemotherapy administered as preventive
centi-Gray
Chemotherapy Yes treatment for an earlier stage of this cancer.
/ Rads
(2285)
Root of administration: Stop Date: the end date for previous
chemotherapy administered as preventive
Oral treatment for an earlier stage of this cancer.
mille-curie
Intravenous (IV) (2287)
Intra-peritoneal (IP) # of Cycles: The total number of cycles
# of fractions:IP
IV and (courses) administered to the patient of a
protocol specified drug or therapy agent.
Other (62590)
Drug Used: the name of the agent or regimen
Specify_____________________ of adjuvant Cytotoxic chemotherapy that was
administered. (2464267)
Total Dose given: Agent total cumulative dose
_____________________ (1515)
Start Date: /
/
MM D
D Y Y
End Date: /
/
1 MM D
D2 Y Y
3
# of cycles give:
Drugs used Total dose given
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TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e
Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 2 Clinical Data (Page 6 of
10)
Tier # Data Element Entry Alternatives caBIG Definition
2: 16 Adjuvant (Post-operative) No Start Date: The start date for previous
Immunotherapy immunotherapy administered as preventive
Yes
treatment for an earlier stage of this cancer.
Start Date: / (2293)
/ Stop Date: The end date for previous
MM D immunotherapy administered as preventive
treatment for an earlier stage of this cancer.
D Y Y
(2295)
Drug Used: Name of a adjuvant
End Date: / immunotherapy agent administered to an
individual.[Manually-curated] (2759176)
/
# of Cycles: The total number of cycles
MM D (courses) administered to the patient of a
D Y Y protocol specified drug or therapy agent.
(62590)
1 Total Dose given: Agent total cumulative dose
of
# 2 cycles give: (1515)
3
Drugs used Total dose given
2: 17 Adjuvant (Post-Operative) No
Hormonal therapy Yes Subha and Peter to curate
Start Date: /
/
MM D
D Y Y
End Date: /
/
MM D
D Y Y
1
of
# 2 cycles give:
3
Drugs used Total dose given
2: 18 Adjuvant (Post-operative) No
Targeted Molecular Therapy Yes Subha and Peter to curate
Start Date: /
/
MM D
D Y Y
End Date: /
/
MM D
D Y Y
Specify:
___________________________
___________________________
___________________________
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TCGA Clinical Data Reporting Form - Ovary Barcod
TSS Name:_________________ TSS e
Internal Use Only
#:
IdentifierTSS Unique Patient # _____________________
Tier 2 Clinical Data (Page 7 of
10)
Tier # Data Element Entry Alternatives caBIG Definition
2: 21 Vital Status Living The state or condition of an individual_s
A. Living Tumor Free neoplasm at a particular point in time.
With (2759550)
B. Dead Tumor
Unknown
Tumor Status
Dead The state or condition of an individual_s
Tumor Free neoplasm at a particular point in time.
With (2759550)
Tumor
2: 00A Race Unknown Race (2192199)
American Indian or Alaska Native (A
person having origins in any of the original
Tumor Status
peoples of North and South America (including
Central America), and who maintains tribal
affiliation or community attachment)
Asian (A person having origins in any of the
original peoples of the Far East, Southeast Asia,
or the Indian subcontinent including, for
example, Cambodia, China, India, Japan, Korea,
Malaysia, Pakistan, the Philippine Islands,
Thailand, and Vietnam)
White (A person having origins in any of the
original peoples of Europe, the Middle East, or
North Africa)
Black or African American (A person
having origins in any of the black racial groups of
Africa. Terms such as "Haitian" or "Negro" can be
used in addition to "Black or African American.")
Native Hawaiian or other Pacific Islander
( A person having origins in any of the original
peoples of Hawaii, Guam, Samoa, or other Pacific
Islands)
Not Reported (Not provided or available)
Unknown (Could not be determined or
unsure)
Not Hispanic or Latino (A person not
meeting the definition for Hispanic or Latino)
Hispanic or Latino (A person of Mexican,
Puerto Rican, Cuban, Central or South American
Ethnicity or other Spanish culture or origin, regardless of
race)
Not reported (Not provided or available)
Unknown (Could not be determined or Ethnicity (2192217)
unsure)
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